Infused vegetable, herb, and/or seed fiber product and dietary supplements containing same

ABSTRACT

Disclosed is a method of producing a reconstituted fruit, herb, and/or seed fiber product, the product produced using the method, and dietary supplements containing the product. The steps used to produce the product include expressing juice from a fruit, herb, or seed; concentrating the juice by removing water; infusing pomace obtained during expression of the juice with the concentrated juice, and drying the steeped pomace to obtain a dry, non-hygroscopic, free-flowing nutritional supplement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional under 35 USC § 120 to application Ser.No. 09/303,808, filed Apr. 30, 1999, now U.S. Pat. No. 6,231,866, whichclaims priority to provisional patent application Ser. No. 60/083,566,filed Apr. 30, 1998, the entireties of both are incorporated byreference herein.

FIELD OF THE INVENTION

The invention is directed to: (i) a method of producing a reconstitutedvegetable, fruit, herb, and/or seed product, the product produced usingthe method, and dietary supplements containing the product; (ii) othermethods which provide all natural solutions for carrying and deliveringnutraceutical supplements into the human body; and (iii) a uniquecranberry nutraceutical product which can be used effectively to promoteand maintain a healthy urinary tract.

DESCRIPTION OF THE PRIOR ART

Currently, powdered forms of cranberries and of many other fruits,produced for use as ingredients, are made from the juice portion of thefruit only. The juice is extracted from the whole fruit by pressing andthen concentrating. During this stage, the plant-derived fiber portion,otherwise known as the pomace or marc, of the fruit is discarded, andthe natural pectin in the juice is removed. The remainder fruit juiceproduct is then spray dried, using a high-heat drying method to removemost of the moisture, which reduces it to a powder. This final powderingredient is a substantially-depleted version of the whole fruit plant,bearing little resemblance to the values contained in the completefruit.

These powdered fruit ingredients, now devoid of many of the importantactive components and enzymes which synergistically existed in the wholefruit plant, deliver little therapeutic value when incorporated intonutraceutical products.

For example, many of the cranberry dietary supplements sold in themarketplace today indicate a dosage requirement of as many as six totwelve tablets or capsules a day because of the weak efficacy of thepowdered cranberry ingredient used.

Thus, there is a distinct need for a new method which will produce newpowdered fruit ingredients, and for new cranberry and other fruitpowdered compositions, which are not so depleted as described and whichinstead incorporate all, or even more, of the values contained in theoriginal fruits.

In another respect, powdered fruit ingredients tend to be hygroscopicand easily agglutinatable. This characteristic substantially affects theflow capability of these ingredients when being transferred intocapsules or softgels for use as dietary supplements. To overcome thisproblem, unnatural excipients are currently added to the fruitingredients in order to facilitate encapsulation. However, the use ofthese excipients presents further problems of then being able to meettapped bulk density specifications. Further, for the natural productsindustry, the use of unnatural excipients is not desired.

Thus there is a distinct need in the marketplace: (i) for a method whichwill enable the production of powdered fruit ingredients which arenon-hygroscopic; (ii) for a method which will improve the flowcharacteristics of these ingredients sufficiently to eliminate the needto use excipients during encapsulation; and (iii) for an all-naturalmethod of achieving these objectives.

In yet another respect, the objective of nutraceutical dietarysupplements is to deliver active compounds into the human body on anefficacious basis. However, many of these supplements after oralingestion are substantially degraded by stomach acids before they candeliver their payload to the intestine for assimilation into the bloodstream. For example, most of the cranberry powdered ingredients beingcurrently employed in dietary supplements dissolve quickly in thestomach and thus have limited bioavailability. While there are variousdrug delivery systems used in the pharmaceutical industry to increaseefficacy, there is an absence of methods available for natural deliveryof nutraceutical products.

Thus there is now a clear and compelling need in the marketplace for amethod of naturally delivering nutraceutical products effectively intothe human body.

In yet another respect, cranberries have a long and well-documentedhistory of being used in the maintenance of urinary tract health. Modernresearch has shown that cranberry fruit contains compounds which arebacteriostatic and particularly aid in the prevention of urinary tractinfections (UTI's). It is believed that this activity is manifested bycompounds which limit the ability of bacteria to adhere to surfaceswithin the urinary tract. Research has shown that at least one of thesecompounds is similar in activity to the Tamms-Horsfall glycoprotein, acompound which inhibits the adherence of E. coli to the bladder wall.See: Avorn, et al., “Reduction of Bacteriuria and Pyuria After Ingestionof Cranberry Juice,”(1994) J. Amer. Med. Assoc. 271:751-754; Fowler,“Urinary Tract Infections in Women,” Urol. Clinics of N. Amer. (1986)13(4):673-683. A recent study further found that the compounds incranberry directly affected the cell structure of E. coli, and disabledthe bacteria so that it was unable to adhere to urothelium and to beless capable of survival. See Ahuja, J., et al., J. Urol 1998:159:559-562.

Based on the known effects of cranberry juice in the maintenance ofurinary tract health, many people now include cranberry juice as part oftheir regular diets. However, most commercially-available cranberryjuice cocktails contain large amounts of added sugar and colorants,additives which many health-conscious individuals find objectionable.Diabetics, for example, often find the sugar content ofcommercially-prepared cranberry juice cocktails to be so high as tooffset any benefits provided by the juice itself.

As a consequence, there has been a long-felt need for a dietarysupplement which: (i) provides the proven health benefits of cranberryjuice without the disadvantages inherent in the cranberry juiceconcoctions which are currently offered in the market place; and (ii) ispowerful enough to only require one tablet a day as the recommendeddaily dosage to be effective.

And yet in another respect, many other fruits, vegetables, herbs, andseeds in addition to cranberries have been scientifically shown or arewidely believed through apocryphal evidence, to have other beneficialhealth effects. For example, bilberries and blueberries are reported toreduce macular nerve degeneration and to improve eyesight. Saw palmettohas been found to reduce prostate swelling. St. John's Wort is believedby many to have antidepressant activity. Garlic is thought to haveantibacterial activity. Ginkgo biloba is believed to improve memory, andginseng is believed to improve attentiveness. Additionally, extracts ofNigella sativa have been shown scientifically to inhibit the growth andproliferation of certain cancers and to increase immune function. SeeU.S. Pat. Nos. 5,482,711 and 5,653,981 to Medenica. Various naturalingredients have been ascribed to act as aphrodisiacs.

In their natural forms, most of these fruits, vegetables, herbs, andseeds cannot be directly ingested (due to palatability as well as otherconcerns). Many of the extracts produced from them have only captured aportion of the bioactive compounds. There is thus a distinct need for anew processing method which can capture the full synergistic andbeneficial activity of these plants in a palatable concoction whichretains the beneficial activity of the natural forms, and also providesfor easy transport, easy formulation into unit dosages, and long-termshelf life without the need for refrigeration.

And in a final respect, tea has been used for centuries as both abeverage and an herbal remedy. The cranberry teas in the market areflavored beverages. There is a distinct need in the marketplace for amethod to make a nutraceutical cranberry tea.

SUMMARY OF THE INVENTION

This invention relates to a method of naturally reconstituting a wholeplant to make a powdered nutritional pharmacological ingredient from theplant which is far richer in vitamins, anthocyanins, proanthocyanins,antioxidants and other components on a concentrated basis than areotherwise naturally proportionately present in the plant.

In another respect, the invention pertains to an all natural method forproducing powdered ingredients which are non-hygroscopic and which haveenhanced flow characteristics without the use of unnatural excipients.

In yet another respect, the invention concerns an all natural uniquemethod of orally delivering nutraceutical compositions into the humanbody in such a manner that the bioactive compounds contained therein aremore effectively absorbed and utilized in the human body.

In yet another respect, the invention pertains to a cranberry-basednutraceutical composition containing active components which inhibit theadhesion of bacteria to surfaces in the urinary tract and which assistsin the promotion and maintenance of a healthy urinary tract.

In yet another respect, the invention pertains to a method for producinga cranberry-based nutraceutical tea.

In yet another respect, the invention pertains to a method of producinga highly concentrated, unpurified dietary fiber product derived fromplants.

A first embodiment of the invention is directed to a dietary supplementproduced by infusing plant-derived fiber with juice concentrate derivedfrom the same or different plant and drying the infused fibers. The term“plant-derived fiber” is also sometimes referred to in this and otherpublications as “pomace,” “marc,” and “press cake.” For purposes of thisapplication, the plant-derived fiber portion will be referred to aspomace.

In a first step, juice is expressed from plant material of fruits,vegetables, herbs, spices, etc. (hereinafter referred to collectively asplants) and seeds of plants, thereby yielding a juice portion and apomace portion. The juice portion is concentrated to yield a juiceconcentrate, and the juice concentrate is then infused with the pomaceportion, whereby the concentrate is absorbed into the pomace. The pomaceso treated is then dried and milled and optionally tableted orcapsulated.

A second embodiment of the invention is directed to a dietary supplementalternatively produced by infusing pomace with oil or other extractderived from the same or a different plant and drying the infusedfibers. In a first step, the oil or other extract is expressed fromplant material of plants, thereby yielding an oil or extract portion anda pomace portion. The oil or extract portion is then infused with thepomace portion, whereby the oil or extract is absorbed into the pomace.The pomace so treated is then dried and milled, and optionally tabletedcapsulated.

A third embodiment of the invention is directed to a highlyconcentrated, unpurified nutritional dietary fiber product produced frompomace derived from the same or different plant and made into a powderedform. In a first step, juice is expressed from plants, thereby yieldinga juice or oil portion and a pomace portion. The juice or oil portion isdiscarded. The pomace is then dried, optionally blended with a gum orother water-soluble fiber, and milled.

A fourth embodiment of the invention is drawn to the product producedusing the process described immediately above.

The invention is an edible 100% plant matter composition which can beused as a nutritional ingredient in place and instead of other highlyconcentrated, unpurified fiber products such as bran, gum orpsyllium-seed husk. It can also be presented in unit dosage form topromote and maintain a healthy life. In the case where cranberries areutilized as the plant material source, the composition is a cranberryfiber, product containing some of the bioactive values of cranberries.

The preferred composition comprises cranberry pomace, which is dried andblended with a gum or alternatively another water-soluble plant fiberand then milled to a roughly uniform size, and optionally formed intotablets or capsules, in the absence of any colorants, sweeteners,unnatural binders, excipients or any other accessory ingredient.

The composition has the same non-hygroscopic and flow features asdescribed above in the second embodiment of the invention. In short,this composition is also comprised entirely of plant-derived fiber.

The composition is manufactured by first removing from the plant matterall plant-derived juice, oil or other liquid extract during a pressingoperation. The pomace is then dried, optionally blended with a gum orother water-soluble fiber, milled and shipped in bulk. The compositionmakes an excellent natural nutritional ingredient and can be used as afood additive for fortification of fiber bars, cereals, breads, drinksand the like, or it can be optionally pelleted, tableted or capsulatedfor use as dietary supplement to be orally ingested.

The preferred plant fiber for use in this embodiment of the invention isthe pomace taken directly from the presses used to express the juice,oil or other liquid extract from the plant material.

However, it is within the scope of the invention to mix the pomaces andjuices. For example, there may be value in infusing the concentratedjuice of cranberries into the pomace derived from apples, blueberries,carrots, squash or other plants. The pomace need not be dried prior toits use in the invention.

In use, the composition, capsulated or not, is ingested orally as adietary supplement to promote the general health of the user. Thecomposition can also be used as a food additive for fortification offiber bars, cereals, breads, and drinks.

In addition to its clear health benefits, another distinct advantage ofthe present invention is that it that it utilizes plant-derived pomace,which would otherwise be discarded as waste. For example, when cranberryjuice concentrate is added to the cranberry pomace, the resultingreconstituted cranberry product makes an excellent nutritionalsupplement which does not require nutritionally insignificant excipientssuch as sweeteners, desiccants, binding agents, and the like.

Further benefits of the present invention are manifest. Byreconstituting concentrated juice with the natural fibers, thenutritionally- and pharmacologically-active ingredients present in thevegetable, fruit, herb, or seed are concentrated in comparison to theirconcentrations as found in nature. Consequently, the bioactive compoundsfound naturally in the plants are fortified. Also, on a per weightbasis, the resultant product is far richer in beneficial vitamins,anthocyanins, proanthocyanins, antioxidants, and other beneficialcomponents.

Moreover, the process and the resultant product utilize the entirenatural source, including the vegetable, fruit, skin, seeds, and fibrousportions thereof, and not simply an extract of the natural plant source.

In essence, the process yields a powdered version of an entirevegetable, fruit, herb, or seed. The resultant product contains thecomplete complement (juice, skin, seeds, fiber) of the source vegetablematter, not just the juice portion. By utilizing only low-temperatureprocessing, the resultant product preserves the natural enzymeactivities found in the fresh vegetable, fruit, herb or seed. In itspreferred form, the process does not require any unnatural substances;hence the finished product does not contain any unnatural substances.However, it is within the scope of the present invention to add otheringredients if desired.

Additionally, the final product is capable of being finely milled andcan therefore easily be formulated into any number of unit dosage forms,such as tablets or capsules. The product need not be refrigerated and isstorage stable for at least a period of months, if not years. This makesformulation, storage, and transport of the product extremely attractive.

When formulated into unit dosages, such as tablets or capsules, theproduct of the invention is easily delivered orally. Because thebioactive ingredients are infused into a generally fiber matrix, thebioactive components are shielded from degradation during transitthrough the stomach, thereby delivering a maximum concentration ofbioactive ingredients in the intestines. The natural pectin componentsof the product slow down the digestive process in the intestines andprovide a natural sustained release of the active compounds from thefiber matrix, thereby enhancing the bioavailability of the activecompounds. The insoluble fiber portion, while indigestible, serves as abulking agent to promote regularity and good intestinal health andfunctioning.

Virtually any plant material, including whole plants, whole fruits,whole vegetables, spices, herbs, seeds, skin, bark, leaves, roots,tubers, or parts thereof, may be used in the present invention. It ispreferred that an entire fruit or vegetable or an entire plant be used,although this is not required. The preferred plant materials to beutilized in the invention fall into two categories: Category I: wholecranberries, blueberries, bilberries, aronia and raspberries; andCategory II: Nigella sativa, saw palmetto, alfalfa, and Echinacea.Preferably, each of these materials is formulated separately to yield apowdered product derived from a single plant source. However, ifdesired, mixtures of various plant materials may be commingled andprocessed simultaneously.

Further advantages of the invention will appear from a complete readingof the Detailed Description, below.

DETAILED DESCRIPTION OF THE INVENTION

The discussion which follows is limited to a description of theparticular, preferred formulation of the present invention,-which is adried formulation derived from whole cranberries. This limitation,however, is for brevity only. As noted above, virtually any plantmaterial, including whole plants, whole fruits, whole vegetables,spices, herbs, seeds, skin, bark, leaves, roots, tubers, or partsthereof, may be used in the present invention. It is preferred that anentire fruit or vegetable or an entire plant be used, although this isnot required. The preferred plant materials to be utilized in theinvention fall into two categories: Category I: whole cranberries,blueberries, bilberries, aronia and raspberries; and Category II:Nigelli saliva, saw palmetto, alfalfa, and Echinacea, with the mostpreferred being cranberries. The process as described below forcranberries is the same process which is used when processing any plantsset forth in Category I or similar.

The dietary supplement disclosed herein which is formulated fromcranberries has been given the name CRAN-MAX, which term shall be usedto designate the product described hereinbelow.

CRAN-MAX is produced by infusing cranberry juice concentrate intocranberry pomace from which the juice has already been expressed. Byremoving the juice from the pomace, concentrating the juice, and thenreuniting the juice with the pomace, a dietary supplement which is farricher in vitamins, anthocyanins and proanthocyanins (OPC's),antioxidants, and other compounds found naturally in cranberries (but infar reduced concentrations) is produced. CRAN-MAX can be taken in pillor capsule form to afford an individual the known benefits of cranberrywithout ingesting unwanted additives such as sweeteners and colorantsfound in commercially available cranberry concoctions.

The first step in producing CRAN-MAX is to express juice fromcranberries. This is accomplished by any of several means known to theart. The physical maceration and expression of juice from the fibrousmatrix of plant material has been known for millennia. Juice from freshcranberries is expressed as soon as practicable after harvest using anytype of suitable means for pressing. For small batches, a hand-poweredhydraulic basket press is perfectly suitable. For larger volumes ofcranberries, industrial-sized equipment is required. Any debris isremoved from the juice by filtration. It is preferred that the juice beprocessed immediately after expression or promptly frozen for storageuntil further processing is undertaken. Likewise, the pomace is eitherused promptly or frozen until needed.

Fresh, single-strength cranberry juice generally has a concentration ofabout 5-7 brix, depending upon the source and condition of the fruit.For use in the formulation of CRAN-MAX, the single-strength juice isconcentrated to at least about 50 brix or higher. This can be done byany means known in the art, such as reduced-pressure evaporation,conventional dehydration, and the like. Preferably the concentration ofthe cranberry juice concentrate falls between about 50 and about 65brix.

The pomace can be used directly or promptly frozen for storage untilfurther processing is undertaken. The pomace is then dried prior tobeing mixed with the juice concentrate.

The juice concentrate and the pomace are preferably mixed at a ratioranging from between about 1:1 (juice concentrate to pomace) to 1:4(wt/wt) based upon a 50 brix juice concentrate and the calculated dryweight of the pomace. See Example 3, below for a 1:1 formulation ofCRAN-MAX starting from 50 brix juice concentrate.

The pomace and concentrated juice are then combined in a batching vesselalong with an amount of guar gum for binding purposes. Additionalnutritional and/or nutraceutical substances from the group consisting ofvitamins, minerals, herbs, and the like, may be added during the mixingstage. The ratio of juice concentrate to pomace is established prior tothe addition of any further ingredients.

The juice and pomace and any additives are mixed thoroughly to ensurethat the entire bulk of the pomace is contacted by the concentratedjuice. Preferably, this mixing is done at a temperature between about40° F. and 75° F. The mixture is allowed to steep for up to 24 hours toallow the liquid to be fully absorbed into the pomace.

The pomace/concentrate mixture is then dried. This can be done on dryingracks in a conventional dehydrator or by vacuum drying means, or by anyother means for drying known to the art of food and pharmaceuticalprocessing. Low-temperature drying means (not to exceed about 140° F.)are greatly preferred. It is preferred that the moisture content of thedried mixture be no more than about 3% by weight.

The dried product so derived using cranberries as the starting plantmaterial is called CRAN-MAX. The CRAN-MAX is then milled to a uniformsize if desired. Generally, milling to a mesh size of between about 50and about 80 yields a product which readily flows and can easily bepackaged, transported, and formulated into dosage form (if desired). A50-80 mesh CRAN-MAX powder is easily pelletized or capsulated usingsuitable and conventional machinery.

CRAN-MAX powder is non-hygroscopic and therefore does not require theuse of desiccants. It should also be noted here that the productsimilarly produced from another plant source is also non-hygroscopic anddoes not require the use of desiccants.

The composition described herein, whether from cranberries or anotherplant source, either alone or in combination with other nutritionallysignificant compounds can be used in the formulation of dietarysupplements, nutraceuticals, or pharmaceutical compositions fornutritional and/or medical use. Nutraceuticals are foods that havespecific medicinal as well as nutritional benefits. The composition maybe optionally formulated with an acceptable carrier therefor andoptionally other therapeutically active ingredients. The carrier, if oneis utilized, must be pharmaceutically acceptable in the sense of beingcompatible with the other ingredients of the formulation and notdeleterious to the recipient thereof.

The formulations are suitable for oral administration only.

The formulations may conveniently be presented in unit dosage form andmay be prepared by any of the methods well known in the art of pharmacy.All methods include the step of shaping the product into desired unitdosage form or packaging the product into unit dosages, such ascapsules. If a carrier is used, such methods also generally include thesteps of bringing the active compound into association with a carrierand one or more optional accessory ingredients. In general, theformulations are prepared by uniformly and intimately bringing theactive compound into association with a liquid or solid carrier and thenshaping or packaging into discrete unit dosages.

Formulations of the present invention suitable for oral administrationmay be presented as discrete units such as capsules, cachets, tablets,boluses or lozenges, each containing a predetermined amount of theCRAN-MAX product as a powder or granules or small fibers.

A tablet may be made by compression or molding, optionally with one ormore accessory ingredients. Compressed tablets may be prepared bycompressing the CRAN-MAX in a suitable machine in a free-flowing form,e.g., a powder or granules, optionally mixed with accessory ingredients,e.g., binders, lubricants, inert diluents, surface active or dispersingagents. Molded tablets may be made by molding in a suitable machine, amixture of powdered CRAN-MAX with any suitable carrier (optional). Theamount of CRAN-MAX present may be in a unitized amount of between about100 mg to about 500 mg.

The amount of the composition required to be effective for promoting andmaintaining sound health, will, of course, vary with the plant materialused in the formulation of the composition and the individual mammalbeing treated and is ultimately at the discretion of the individual, ormedical or veterinary practitioner.

In general, the pharmaceutical compositions of this invention containfrom about 50 to about 5000 mg of CRAN-MAX, and preferably from about300 to about 1000 mg. of CRAN-MAX, preferably in a unit dosage form. Therecommended dosage of CRAN-MAX is 500 mg a day, preferably in a singledose, which has been determined by laboratory analysis and confirmed byclinical evaluation. See Example 7 below.

CRAN-MAX powder contains more antioxidant activity than straightcranberry juice and has an organic acid content that is comparable tothat of commercially-available, single-strength cranberry juice (see theExamples).

Plants in Category 2 referenced above require a different process thanthat used for plants in Category 1 referenced above. The processdescribed below for saw palmetto is the same process which is used whenprocessing any plants set forth in Category 2, or similar.

The dietary supplement disclosed herein which is formulated from sawpalmetto has been given the name SAW-MAX, which term shall be used todesignate the product described below.

SAW-MAX is produced by infusing saw palmetto oil into saw palmettopomace. The saw palmetto oil is obtained from saw palmetto seeds fromwhich the oil has been expressed. By infusing the oil from the seedsinto the pomace, a dietary supplement which is far richer in sawpalmetto (but in far reduced concentrations) is produced. SAW-MAX can betaken in pill or capsule form to afford an individual the known benefitsof saw palmetto in a more potent form.

The first step in producing SAW-MAX is to dry the saw palmetto berries(containing seeds) after they have been picked from the plants. This canbe done on drying racks in a conventional dehydrator or by vacuum dryingmeans, or by any other means for drying known to the art of food andpharmaceutical processing. Low-temperature drying means (not to exceedabout 140° F.) are greatly preferred. It is preferred that the moisturecontent of the dried mixture be no more than about 3-5% by weight.

The dried berries (containing seeds) are then milled to about 30 mesh.The berries are then subjected to an extraction process used to expressoil from the seeds. This is accomplished by CO₂ super criticalextraction, a means known to the art. Oil from the seeds in the berriesis expressed during this process in an amount by weight of between 6%and 12% of the weight of the seeds. The pomace residue is gathered andmilled to a mesh size of between about 60 to about 80.

The expressed oil and pomace are preferably mixed at a ratio rangingfrom 1:3 (oil to pomace) to 1:6 (wt/wt). The oil and pomace are thencombined in a batching vessel. Additional nutritional and/ornutraceutical substances from the group consisting of vitamins,minerals, herbs and the like, may be added during the mixing stage. Theratio of oil to pomace is established prior to the addition of anyfurther ingredients.

The oil and pomace and any additives are thereupon thoroughly blended ina ribbon blender to ensure that the entire bulk of the pomace iscontacted by the oil. Preferably, this blending is done at a temperaturebetween about 40° F. and 75° F. The blending takes 3 to 5 hours for theoil to be completely saturated into the pomace.

The product so derived using saw-palmetto berries as the starting plantmaterial is called SAW-MAX. It readily flows and can easily be packaged,transported, and formulated into dosage form (if desired). The powder iseasily pelletized or capsulated using suitable and conventionalmachinery.

SAW-MAX powder is non-hygroscopic and therefore does not require the useof desiccants. It should also be noted here that the product formulatedfrom any product similarly produced from another plant source inCategory 2 is also non-hygroscopic and does not require the use ofdesiccants.

The composition described herein, whether from saw-palmetto or anothersimilar plant source, either alone or in combination with othernutritionally significant compounds can be used in the formulation ofdietary supplements, nutraceuticals or pharmaceutical compositions fornutritional and/or medical use. The composition may be optionallyformulated with an acceptable carrier therefor and optionally othertherapeutically active ingredients. The carrier, if one is utilized,must be pharmaceutically acceptable in the sense of being compatiblewith the other ingredients of the formulation and not deleterious to therecipient thereof.

The formulations are suitable for oral administration only. Theformulations may conveniently be presented in unit dosage form and maybe prepared by any of the methods well known in the art of pharmacy. Allof the above methods described above under CRAN-MAX are similarlyapplicable in this case.

Another aspect of the invention, an all natural method of orallydelivering nutraceutical products, has been given the name BIO-SHIELD,which term shall be used to designate the method described below.

The BIO-SHIELD method comprises using a composition produced using themethod described above for producing CRAN-MAX or SAW-MAX, placing thiscomposition into a capsule or tablet and then orally ingesting it.

Because the bioactive ingredients are infused into a fiber matrix, thebioactive components are shielded from degradation during transitthrough the stomach, thereby delivering a maximum concentration ofbioactive ingredients into the intestines. The natural pectin componentsof the product slow down the digestive process in the intestines andprovide a sustained release of the active compounds from the fibermatrix, thereby enhancing the bioavailability of the active compounds.

Another aspect of the invention is a highly concentrated, purified fiberproduct given the name FIBER-X, which term shall be used to designatethe product described below. FIBER-X is produced from the pomace of anyof the plants described herein, following removal of the juice or oilcomponent. The fiber is rich in the bioactive compounds found in thoseplants and has value as a nutritional bulking agent.

Two different sequences are employed, depending upon whether the plantsource is a Category 1 or Category 2 plant, as referenced above.

Where the plant source is a Category 1 plant, the extracted juice isdiscarded. The pomace remaining after pressing is thereupon dried andmilled, using the same drying and milling methods and specifications asdescribed above for CRAN-MAX.

Where the plant source is a Category 2 plant, the same drying, initialmilling and extraction methods and specifications are the same as thosedescribed above under SAW-MAX. However, in this case the oil obtainedfrom the extraction process is discarded. The pomace residue has a smallamount (1-2% by weight) of oil contained within its fiber matrix, alongwith other bioactive compounds found naturally in the plant. The pomaceis remilled again to a mesh of between about 60 and about 80.

The dried product so derived from either of these methods is calledFIBER-X which is a 100% edible plant matter composition. In each casedepending upon the plant material source utilized, the composition is afiber product containing some of the particular bioactive values of thatplant source.

FIBER-X can be used as a nutritional ingredient in place and instead ofother highly concentrated, unpurified fiber products such as bran, gumor psyllium-seed husk. In bulk, the composition makes an excellentnatural nutritional ingredient and can be used as a food additive forfortification of fiber bars, cereals, breads, drinks and the like.

Optionally, it can be presented in unit dosage form to promote andmaintain a healthy life, pelleted, tableted or capsulated for use as adietary supplement to be orally ingested.

The preferred composition comprises cranberry pomace, which is dried andblended with a gum or alternatively another water-soluble plant fiberand then milled to a roughly uniform size, and optionally formed intotablets or capsules, in the absence of any colorants, sweeteners,unnatural binders, excipients or any other accessory ingredient.

The composition has the same non-hygroscopic and flow features adescribed above in the second embodiment of the invention. In short,this composition is also comprised entirely of plant-derived fiber.

Another aspect of the invention is a nutraceutical tea, comprising theblend produced using the entire method described in CRAN-MAX above withthe exception that the product produced is milled instead to a tea cutof between 12 and 16 mesh.

EXAMPLES

The following Examples are included solely to aid in a more completeunderstanding of the subject invention. The Examples do not limit thescope of the invention described herein in any fashion.

Example 1

Production of CRAN-MAX.

CRAN-MAX was produced by combining 1430 pounds cranberry fiber, 65%moisture content, with 99 gallons of cranberry juice concentrate (50brix, 10.2 pounds per gallon), to yield a total weight of 2430 pounds.Both the cranberry fiber and the concentrate were delivered frozen andthawed immediately prior to formulation.

The fiber and concentrate were mixed thoroughly, whereby the concentratewas absorbed completely into the fiber. The mixture was then vacuumdried (final moisture 1.75%) and milled to 50 mesh. This yielded afree-flowing, non-hygroscopic powder formulation having a naturalrose-colored hue.

Example 2

Production of CRAN-MAX Plus Vitamin C.

A batch of CRAN-MAX was prepared in the same fashion as described inExample 1 with the exception that 250 pounds of ascorbic acid (VitaminC) was added to the concentrate prior to mixing the concentrate with thefiber. The ascorbic acid was added to the concentrate with continuousagitation, and this mixture then added to the fiber. The combination wasthoroughly mixed, vacuum dried (1.75% final moisture), and milled to 50mesh. The resultant product was also a free-flowing, non-hygroscopicpowder having a natural rose-colored hue.

Example 3

Production of CRAN-MAX Using Cranberry Juice Concentrate of VaryingBrix.

CRAN-MAX was produced using a 1 to 1 weight ratio of fiber to 50 brixjuice concentrate. Wet fiber (396 g) having a moisture content of 63.84%by weight yielded a dry fiber weight of 143 grams. To the wet fiber wasadded 143 grams of 50 brix concentrate, which is equivalent to adding0.157 pound juice solids to the fiber. The mixture was dried and milledas in Example 1.

To formulate an equivalent amount of CRAN-MAX using 65 brix concentrate,110 g of concentrate was added to the same amount of fiber. Thecalculation appears as follows:

(amt of 65 brix concentrate)(7.135 pound solids @ 65 brix)=0.157

(amt of 65 brix concentrate)=0.022 gal=83.3 ml=110 g concentrate

Example 4

Comparison of ORGANIC ACID CONTENT IN CRAN-MAX V. CRANBERRY JUICE.

Samples of CRAN-MAX prepared as described in Example 1 and commerciallypurchased cranberry juice were analyzed by reverse phase HPLC using anorganic acids column and UV detection means to determine the percentageof quinic, malic, and citric acids found therein. The results arepresented in Table 1:

TABLE 1 Organic Acids (%)^(a) Sample Quinic Malic Citric Total CRAN-MAX2.1 5.0 3.8 10.9^(b) Commercial 1.6 6.8 2.7 11.1^(c) Cranberry Juice^(a)Values determined by reverse-phase HPLC with UV detection based onappropriate standard solutions. ^(b)% w/w ^(c)% w/v

Example 5

Antioxidant Activity of CRAN-MAX

A sample of CRAN-MAX produced according to Example 1 was analyzed forits oxygen-radical absorbance capacity (ORAC) using a standard assay.

The assay utilizes 2,2′-azobis(2-amidinopropane)dihydrochloride) (AADH)as a peroxyl radical generator and B phycoerythrin as an indicatorprotein. “TROLOX,” a water-soluble Vitamin E analog, is used as areference point for antioxidant activity. One ORAC Unit is defined asthe oxygen-radical absorbance capacity of a 1 MM solution of “TROLOX.”The assay is constructed by combining the phycoerythrin and thecomposition to be tested into an aqueous solution and then adding theAADH and monitoring the reaction solution by fluorescence at 565 nm(excitation at 540 nm).

Serial dilutions of CRAN-MAX, cranberry juice, and “TROLOX” wereassembled and aliquots of phycoerythrin added thereto. The results aredepicted in Table 2:

TABLE 2 Sample ORAC Units per g “TROLOX” Equivalent Commercial Cranberry9,196 0.007 Juice Cocktail CRAN-MAX 26,227 0.020 Trolox 1,315,780 1.000

Example 6

Calculation of Weight Ratio: Whole Cranberry to CRAN-MAX

A 100 lb. sample of cranberries was juiced in standard fashion, yielding5 pounds of cranberry fiber, a ratio of 20 to 1. One hundred pounds ofwhole cranberries will have an average yield of 1.25 gallons of juiceconcentrate at 50 brix and 10.24 lbs./gallon, which is equivalent to12.8 lbs at 50 brix which is equivalent to 6.4 lbs dry solids. 6.4 lbsjuice solids per 100 lbs whole cranberries yields a ratio of 15.6 to 1.Combining the juice solids with the cranberry fibers in the combinedCRAN-MAX formulation thus yields a final ratio of 34.6 to 1. At thisratio, 500 mg CRAN-MAX contains the same juice solids as about 10 oz. ofcranberry juice concentrate.

Example 7

Clinic Evaluations

Three patients in a urological practice were given a self-assessmentquestionnaire developed by the American Urological Association forassessing symptoms related to benign prostatic hypertrophy. The patientsevaluated the questions on a scale of 0 to 5, 0 designating “none,”“never,” or “not at all” and 5 designating “5 or more times (in thestated period)” or “almost always.” The 7 questions contained in theself-assessment questionnaire were:

1. Over the last month or so, how many times did you most typically getup to urinate from the time you went to bed at night until the time yougot up in the morning?

2. Over the past month or so, how often have you had a sensation of notemptying your bladder completely after you finished urinating?

3. Over the past month or so, how often have you had to urinate againless than two hours after you finished urinating?

4. Over the past month of so, how often have you found that you stoppedand started again several times when you urinated?

5. Over the past month or so, how often have you found it difficult topostpone urination?

6. Over the past month or so, how often have you had a weak urinarystream?

7. Over the past month or so, how often have you had to push or strainto begin urination?

Each of the three patients (two female, one male) completed thequestionnaire and their scores tallied by adding the total numeric valueof their responses. The results were as follows:

Score of Self-Assessment at Beginning of Trial Patient 1 7.5 Patient 2 9Patient 3 8

With full information and consent, each patient was then given a 500 mgdaily dose of CRAN-MAX, in a single dose, for a course of 30 days. Thepatients then completed the self-assessment questionnaire. The scoresafter the 30 course of treatment with CRAN-MAX were as follows:

Score of Self-Assessment After 30-Day Treatment Period Patient 1 2.5Patient 2 6 Patient 3 3

Thus, for these three patients, treatment with CRAN-MAX over a course of30 days resulted in a marked improvement of their self-assessment ofurinary frequency, urgency, etc.

It is understood that the invention is not confined to the particularconstruction and arrangement of parts herein illustrated and described,but embraces such modified forms thereof as come within the scope of theclaims.

What is claimed is:
 1. A method of producing a dietary supplement from avegetable, herb or spice plant material comprising: (a) expressing oilfrom the plant material thereby yielding an oil portion and a pomaceportion; (b) mixing the oil portion with the pomace portion to yield anoil-infused pomace; and then (c) drying the oil-infused pomace to yieldthe dietary supplement.
 2. The method of claim 1, further comprising,prior to step (a), drying the plant material.
 3. The method of claim 2,wherein the plant material is dried at a temperature of less than about140° F.
 4. The method of claim 2, wherein the plant material is dried toa moisture content no more than about 3-5% by weight.
 5. The method ofclaim 1, further comprising, after the drying, milling the plantmaterial to about 30 mesh.
 6. The method of claim 1, further comprising,prior to step (b), milling the pomace to a mesh size between about 60and about
 80. 7. The method of claim 1, wherein in step (b), the oilportion is mixed with the pomace portion at a temperature between about40° F. and 75° F.
 8. The method of claim 1, wherein in step (b), the oilportion is mixed with the pomace portion in an about 1:3 to 1:6 (wt/wt)oil portion to pomace ratio to yield oil-infused pomace.
 9. The methodof claim 1, further comprising, after the mixing, blending theoil-infused pomace in a ribbon blender.
 10. The method of claim 1,further comprising adding additional nutritional and/or nutraceuticalsubstances to the oil portion and the pomace portion in step (b). 11.The method of claim 1, wherein in step (c), the oil-infused pomace isdried to yield a free-flowing, non-hygroscopic powder formulation toyield the dietary supplement.
 12. The method of claim 1, furthercomprising, after step (c): (d) comminuting the dietary supplement to aroughly uniform particle size.
 13. The method of claim 12, wherein thedried product is comminuted to a mesh size between about 50 and about80.
 14. The method of claim 13, further comprising, after step (d): (e)formulating the dietary supplement into unit dosage form.
 15. The methodaccording to claim 1, wherein in step (a), oil is expressed from one ormore plants selected from the group consisting of Nigella sativa, sawpalmetto, Echinacea, and alfalfa.
 16. A dietary supplement produced bythe method recited in claim
 15. 17. The dietary supplement of claim 16,which contains between about 50 and about 5000 mg of the dietarysupplement in a unit dosage form.
 18. The dietary supplement of claim16, which contains between about 300 and about 1000 mg of the dietarysupplement in a unit dosage form.
 19. The dietary supplement of claim16, which contains between about 500 mg of the dietary supplement in aunit dosage form.
 20. A method of producing a dietary supplementcomprising: (a) drying plant material; (b) milling the dried plantmaterial to about 30 mesh; (c) expressing oil from dried plant materialthereby yielding an oil portion and a pomace portion; (d) milling thepomace portion to a mesh size between about 60 and about 80 mesh; (e)mixing the oil portion with the pomace portion to yield a oil-infusedpomace; (f) blending the oil-infused pomace; and then (g) drying theoil-infused pomace to yield the dietary supplement wherein in step (a),the plant material dried is from one or more plants selected from thegroup consisting of Nigella saliva, saw palmetto, Echinacea, andalfalfa.
 21. A dietary supplement produced by the method recited inclaim 20.